Absorption and Metabolic Profiles of a Sugar-based Beverage
SR
Absorption Profile of a Sugar-based Beverage on Inflammatory Mechanism by Timing of Beverage Consumption Relative to Meal Intake.
1 other identifier
interventional
9
1 country
1
Brief Summary
Primary objective is to determine absorption profile of a sugar-based beverage on inflammatory mechanism by timing of beverage consumption relative to meal intake. Secondary objective is to determine absorption profile of a sugar-based beverage on oxidative and metabolic mechanism by timing of beverage consumption relative to meal intake. The results will be served as an internal reference or negative control group to compare with polyphenol containing studies from other studies. Each subject will receive 3 identical placebo drinks at each time points: fasting (0h), with standardized breakfast meal (2h), and 2 hours after the breakfast meal (4h). A planned size of 12 will be recruited into this part of the study. This study is a single-arm design utilizing a multiple sampling, and repeated measures paradigm to evaluate timing influence of consumption of sugar-based beverage associated acute effect on inflammatory markers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2014
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 26, 2014
CompletedFirst Submitted
Initial submission to the registry
August 22, 2014
CompletedFirst Posted
Study publicly available on registry
August 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 13, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2015
CompletedJanuary 26, 2021
January 1, 2021
7 months
August 22, 2014
January 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in inflammation markers over 10 hours after sugar beverage consumption at different time points.
The timing influence of beverage consumption on inflammation markers in relative to meal intake (2 hours before a meal, with a meal, and 2 hours after a meal).
10 hr Postprandial paradigm
Secondary Outcomes (1)
Changes in oxidative stress markers over 10 hours after sugar beverage consumption at different time points.
10 hr
Other Outcomes (1)
Changes in metabolic markers over 10 hours after sugar beverage consumption at different time points.
10 hr
Study Arms (1)
3 Placebo Beverages
EXPERIMENTALSugar beverage 2 hr before meal and with meal and 2 hr after meal
Interventions
Sugar beverage 2 hr before meal, with meal and 2 hr after meal
Eligibility Criteria
You may qualify if:
- years of age and older
- Body Mass Index (BMI) range from 25 to 29.9 kg/m2; exception BMI 23 to 27.4 kg/m2 for Asian population
- Nonsmoker
- No clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal or hepatic disease
- Not taking any medications that would interfere with outcomes of the study, i.e. lipid lowering medications, anti-inflammatory drugs, or dietary supplements.
- Able to provide informed consent
- Able to comply and perform the procedures requested by the protocol Weight stable: not gained or lost weight +/- 5 kg in previous 3 months
You may not qualify if:
- Men and women who smoke
- Past smokers: abstinence for minimum 2 years
- Men and women with known or suspected food intolerance, allergies or hypersensitivity
- Men and women known to have/diagnosed with diabetes mellitus
- Men and women who have fasting blood glucose concentrations \> 125mg/dL
- Men and women who have blood pressure \>140 mmHg/90 mmHg
- Men and women with documented vascular disease, e.g., heart failure, myocardial infarction, stroke, angina, related surgeries.
- Men and women with cancer other than non-melanoma skin cancer in previous 5 years.
- Women who are known to be pregnant or who are intending to become pregnant over the course of the study
- Women who are lactating
- Taking medication or dietary supplements that may interfere with the outcomes of the study; e.g., antioxidant supplement, anti-inflammation, lipid lowering medication. Subjects may choose to go off dietary supplements (requires 30 days washout).
- Men and women who have donated blood within 3 months of the screening visit and blood donors/participants for whom participation in this study will result in having donated more than 1500 milliliters of blood in the previous 12 months.
- Men and women who are vegans
- Substance (alcohol or drug) abuse within the last 2 years.
- Excessive coffee and tea consumers (\> 4 cups/d)
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinical Nutrition Research Center
Chicago, Illinois, 60616, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Britt Burton-Freeman, Ph.D
Illinois Institute of Technology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2014
First Posted
August 27, 2014
Study Start
June 26, 2014
Primary Completion
January 13, 2015
Study Completion
February 20, 2015
Last Updated
January 26, 2021
Record last verified: 2021-01